inforMED
MalfunctionFNL

PANACEA

Received Jan 7, 2025 · Event occurred Aug 20, 2024

Report 1931947-2024-00001 · MDR key 21093248

Device

Generic name

Bed 3500 Mah

Model number

1070014BEI

Catalog number

C7570

Product problems

  • Human-Device Interface Problem
  • Insufficient Device Problem Information
  • Human-Device Interface Problem
  • Insufficient Device Problem Information

Patient

62 YR · Female

  • Neck Pain
  • Neck Pain

Narrative

Additional Manufacturer Narrative

MULTIPLE TESTS WERE COMPLETED WITH THE MAXIMUM SAFE WORKING LOAD OF 600 LBS. TO SIMULATE WHAT COULD HAVE HAPPENED. THE ONLY WAY TESTING COULD GET THE BED TO FAIL IN THE MANNER DESCRIBED WAS TO STRAP THE CASTER BASE TO THE HEAD END OF THE BED TO SIMULATE THE BED RAISING UNTIL IT HIT AN OBSTRUCTION. THE BED WOULD STOP AND THE OPERATOR WOULD HAVE HAD TO REPEATEDLY PUSH THE UP ELEVATION BUTTON TO GET IT TO MOVE AGAIN RESULTING IN BENDING THE ACTUATOR PIN, ARM AND LEG WHICH RESULTED IN PULLING THE LEGS OUT OF THE TRACK AND THE HEAD END OF THE BED COLLAPSING. THE CUSTOMER WAS ADVISED OF TEST RESULTS AND TO LOOK FOR OBSTRUCTIONS THAT COULD BE IN THE ROOM. WATCH FOR THE BED STOPPING OR ONLY MOVING AT ONE END INDICATING THERE IS AN OBSTRUCTION. SCRATCHES UNDER THE BED INDICATE A LIFT WAS USED OR STORAGE WAS UNDER THE BED. DO NOT STORE ITEMS UNDER THE BED.

Additional Manufacturer Narrative

REPORT WILL BE UPDATED AS INFORMATION BECOMES AVAILABLE. REPORTING WITH INFORMATION REASONABLY KNOWN.

Description of Event or Problem

(B)(4). AT 3:23 PM ON (B)(6)2024, (B)(6) CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: BED. (B)(6) REPORTED THAT THE FOLLOWING OCCURRED: (B)(6) SAID SHE WAS TOLD THE RESIDENT SAID THEY GOT WHIPLASH WHEN THE HEAD OF THE BED GAVE OUT. IT IS UNKNOWN HOW MANY PEOPLE WERE PRESENT DURING THE INCIDENT. THE INITIAL REPORT WAS RECEIVED AND STAFF LEFT 3 MESSAGES AND SHE HAD NOT CALLED BACK BY THURS. (B)(6)2024 9:38AM. ON (B)(6)2024 10:47AM WE WERE NOTIFIED OF THE INCIDENT AND THAT THEY WERE ABLE TO CONTACT HER. THE RESPONSE WAS THAT MAINTENANCE FIXED THE ISSUE BUT DIDN'T KNOW HOW IT WAS POSSIBLE TO COME OUT OF THE TRACK. SHE IS A BARIATRIC PATIENT WEIGHT IS 396 LBS. THEY DID NOT REPORT THAT SHE WAS TAKEN FOR TREATMENT OR PROVIDE ANY MEDICAL RECORDS FOR THE ALLEGED WHIPLASH. NO PICTURES OR VIDEOS WERE PROVIDED. THERE WAS LITTLE RESPONSE FROM THE CUSTOMER SO WE SENT A REPLACEMENT BED AND REQUESTED THE BED IN QUESTION BE RETURNED FOR INVESTIGATION. AT THE TIME OF THIS REPORT, THE BED HAS NOT RETURNED FOR INVESTIGATION AND COULD NOT DETERMINE IF IT MALFUNCTIONED. REPORT IS BEING FILED AFTER THE 30 DAY TIMELINE DUE TO CONFUSION REGARDING THE REPORTING OF MDRS WITH LITTLE INFORMATION. WE ARE REPORTING WITH THE INFORMATION REASONABLY KNOWN TO US OUT OF AN ABUNDANCE OF CAUTION.

Remedial action

  • Replace